The Future of Food Safety: FSMA & the State Departments of Agriculture

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Brittney Bond
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1 The Future of Food Safety: FSMA & the State Departments of Agriculture 2015 NGFA/PFI Feed and Pet Food Joint Conference Bob Ehart Senior Policy & Science Advisor

2 Who/What is NASDA? NASDA is the National Association of State Departments of Agriculture We are a nonprofit, nonpartisan organization representing the 50 state and 4 territorial departments of agriculture We are located in the Washington, DC area

3 FSMA primer The FSMA was signed into law in Jan 2011 FSMA adds authorities to the FFD&CA it isn t a stand alone law FSMA establishes preventive controls adding them to cgmps FDA has had authority over causes of foodborne outbreaks and adulterated products Levels the playing field by creating similar requirements for imported and domestic products

4 More on FSMA FFD&CA already regulated manufactured food production and FSMA officially adds preventive controls FFD&CA regulated medicated feed and FSMA adds GMPs and preventive controls to the regulation of animal food production newly regulated facilities FSMA proactively regulates fruit and vegetable producers newly regulated farms and packing sheds

5 7 major rules to implement FSMA Preventive Controls: Animal Food Preventive Controls: Human Food Produce Safety Foreign Supplier Verification Program Third-party Accreditation Intentional Adulteration Sanitary Transportation

6 Why was FSMA passed? While we arguably have the safest food supply in the world, several highly publicized foodborne illness events made food safety front page news Leafy greens Cantaloupe Peppers And we can t forget melamine

7 Prevention: a new paradigm Prevention is an important policy change for several reasons: The old policy is unsustainable It creates a culture where everyone has a new (improved) role in assuring food safety While we will never have zero events, we can improve what we know and what we do to prevent events from occurring

8 Prevention: a new culture If prevention is to work, everyone needs to do their own part: Producers, Suppliers, Wholesale, Retail, Consumers Educators Regulators States FDA

9 Culture Change FDA will have a new role, as a participant in assuring food safety, not just as an enforcement agency Philosophically, state programs have often been based on compliance which we believe is consistent with the role, responsibility and values Congress established in FSMA We all have an opportunity to make prevention work

10 Current states roles States have cooperated with FDA for years Manufactured food programs in state health (~30 states) and agriculture (~20 states) departments Feed control programs (in 47 state agriculture departments the other 3 in universities) Dairy processors regulated through stateenacted Pasteurized Milk Ordinances Fruit & Vegetable producers only reactively

11 FSMA and the states Food Safety Policy needed to be modernized Prevention is a sound public policy No state currently had a Produce Safety or Feed Safety program aligned with the ideals of FSMA FSMA supports the development of an Integrated Food Safety System

12 FSMA and the states FDA needs: to get the rules right to change its culture the states to help the agency implement all three of the major rules Congress needs to fund FSMA

13 FSMA allows states to have a role but does not require states to implement FSMA FSMA supports creating an Integrated Food Safety System for a reason It is inconceivable that the magnitude of changes created by FSMA can be implemented by FDA without the states Congress will not fund FDA at the level it would take to implement FDA as a federal program

14 Educate before and while we regulate This is unchartered territory for FDA New levels of cooperation between federal and state program leaders will be required New and improved links between the regulators and the educators will be required Interactions between and among regulators, educators and industry will also need to increase

15 Developing state programs Look to: existing programs e. g., manufactured foods Existing feed control programs are primarily label guarantee programs however, existing authority regarding adulterated product is a basic tenet of food / product safety New authority will be required

16 Developing state programs We live in interesting times Because of other federal laws creating unfunded mandates, state legislatures are not particularly interested in creating a new state program just because Congress has regardless of the need, value and support for the program FDA needs to get the rules right and Congress needs to fund it

17 Potential Roles for States As partners with FDA As educators state depts of agric & extension As regulators As a buffer between FDA and producers/facilities As compliance and technical assistance counselors including readiness review

18 Options for state involvement First option is for Congress to adequately fund FDA and the states for a core program States would seek state laws that would align with FSMA States would operate under states authorities and cooperate with FDA

19 Options for state involvement Alternatively, states could operate as federal inspectors, using commissioning and credentialing This could be a short term stop gap solution, but is not the preferred option

20 Where the state departments of agriculture are today Did I mention getting the rules right and Congressional funding?

21 Getting the rules right FDA has listened to its stakeholders regarding the definition of farm and what a vertically integrated operation is. We are still analyzing the details for the PC rules, and we will be interested in your take of the PC: Animal Food rule and any problems that still exist in your view.

22 Correcting problems FDA has acknowledged that some issues may still exist. Some officials have indicated that the agency will deal with additional issues through guidance The downside to this approach is that guidance will not apply to imported products

23 Cooperative Agreement between NASDA and FDA for Produce Safety State departments of agriculture have long had interrelations with FDA primarily at the technical program level Under the Cooperative Agreement with NASDA the interactions between FDA and the state agricultural programs are now also at the policy level

24 Cooperative Agreement between NASDA and FDA Provides a link between FDA and the states regarding the implementation of the Produce safety rule. Allows states officials to get organized between agriculture and public health Will create more consistency between state programs

25 Cooperative Agreement between NASDA and FDA The agreement deals only with Produce Safety It is a 5 year agreement It was awarded in Sept 2014 We are in the throes of finalizing the first years deliverables Partners this past year include: AFDO & IFPTI

26 Cooperative Agreement between NASDA and FDA Focuses on several key elements: What are the existing states authorities? What are the existing resources? What would a state-centric operational plan look like?

27 Program management areas Chapter 1 Alignment and Consistency Chapter 2 Foundation of Law Chapter 3 Financial Support Chapter 4 Outreach/Education & Compliance/Enforcement Chapter 5 Work Planning Chapter 6 Information Sharing Chapter 7 Regulator Training Chapter 8 Laboratory Resources Chapter 9 Technical Assistance Chapter 10 Dispute Resolution Chapter 11 Infrastructure

28 Possible similar plan to implement the Preventive Controls: Animal Food rule Most of the philosophical underpinnings are the same for the implementation of Produce Safety and the Preventive Controls: Animal Food AAFCO officials have participated in NASDA s Produce Safety Operational Plan development

29 Possible similar plan to implement the Preventive Controls: Animal Food rule FDA, NASDA and AAFCO have had preliminary discussions regarding a future effort to have the federal policy and technical officials work with the states policy and technical officials to develop an implementation plan for the Preventive Controls: Animal Food rule

30 Funding: A new paradigm for federal-state program coordination: Base level funding to create a workable program A menu of program areas to choose from: Education, Technical Assistance, Readiness Review Compliance and Enforcement This concept is expandable into the other FSMA program areas as well

31 Funding estimates: $20 M for state programs to implement the Preventive Controls: Animal Food rule $40 M for state programs to implement Preventive Controls: Human Food rule $45 55 M for state programs to implement the Produce Safety rule

32 Is Food Safety worth that investment? Bob Ehart

Update on FSMA Implementation. Rebecca Buckner May 24, 2016

Update on FSMA Implementation. Rebecca Buckner May 24, 2016 Update on FSMA Implementation Rebecca Buckner May 24, 2016 Presentation Overview FSMA Implementation Rulemaking and Industry Guidance - Focus on the Preventive Controls Rules FSMA Implementation Guiding